Kornimate/medical-research-clean huggingface dataset:
intrauterine lidocaine infusion for essure sterilization procedures

Conditions: Pain

Summary: the purpose of this study is to assess the level of pain women experience with an essure procedure and the effect that lidocaine might have on that pain. we will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.

we intend to conduct a randomized, blinded, and placebo- controlled clinical trial at oregon health and science university and planned parenthood of the columbia willamette to determine if intrauterine lidocaine infusion will decrease the amount of pain subjects experience during and after essure transcervical tubal sterilization. we plan to enroll women who have selected essure as their method of tubal sterilization who will be randomized to one of two groups on the days of their procedures. subjects in group 1, the treatment group, will receive a standard paracervical block with lidocaine intrauterine infusion and subjects in group 2, the control group, will receive a standard paracervical block with saline intrauterine infusion. the subjects will be asked to rate their pain on a 100 mm visual analog scale (vas) at five points during the procedure and once thirty minutes following the procedure. subjects will also be asked to rate their overall satisfaction with their care prior to leaving the recovery room.

Eligibility criteria:
inclusion criteria: * female * age 18 or older * good general health, based on the opinion of the investigator * voluntarily requesting permanent sterilization * negative pregnancy test * agree to premedication with ibuprofen and ativan * english speaking, or other language if an interpreter is available to be present at all points of the study procedure. * willing and able to sign an informed consent * willing to comply with the terms of the study exclusion criteria: * significant physical or mental health condition, based on the opinion of the investigator. * positive pregnancy test * request for iv/im sedation prior to the start of the procedure * refusal of ibuprofen, ativan, or paracervical block * allergy to any study medication including lidocaine, ibuprofen, ativan, sodium bicarbonate * history of toxic reaction to local anesthetics * known hepatic disease or liver dysfunction. (lidocaine is metabolized by the liver.) * weight less than 100 pounds. \[any patient weighing less than 100 pounds would receive more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)\]. * current participation in another research study which would interfere with the conduct of this study.

Keywords: essure sterilization pain management intrauterine lidocaine infusion
dextran use for primary angioplasty protection in acute myocardial infarction

Conditions: Acute Myocardial Infarction With ST Elevation

Summary: reperfusion therapy in acute myocardial infarction saves viable myocardium, but paradoxically reestablishment of coronary artery flow also induces damage and cell death, decreasing the full benefit of reperfusion in terms of reduction of infarct size and preservation of ventricular function . myocardial reperfusion can in itself produce more damage and cell death, this process defines the phenomenon of reperfusion injury, which could be prevented by applying additional therapies.

during myocardial ischemia, due to lack of o2, the myocyte leaves energy production from the aerobic metabolism of lipids and the production of energy in the form of phosphates will depend, in this situation, on the anaerobic metabolism of glucose. as a result they are consumed muscle glycogen stores that produce little atp, and also generating acidosis. the cell membrane loses its ability to maintain the fluid's electrolyte balance. cellular edema is generated by the entry of sodium and water, leading to cell rupture. during ischemia and reperfusion free radicals are produced that stimulate inflammation and consequently release prothrombotic and cytotoxic substances that also produce cellular damage. due to its osmotic, antithrombotic, anti-inflammatory and rheological effects, dextran could be useful in this scenario. the administration of a solution in the distal bed, for the protection of the myocardium, before opening the epicardial artery is called by us "controlled reperfusion". the researchers think, using a solution with venous blood, containing less o2 but retaining buffer properties; enriched with dextran, which has onctic power, anti-inflammatory and anticoagulant properties, and molecules similar to glucose; results in a potentially useful solution for myocardial protection in this scenario. the group of investigators expect that controlled reperfusion treatment will reduce the incidence of st correction and infarct size by 20-30%, improving the prognosis in terms of mortality and heart failure.

Eligibility criteria:
inclusion criteria: * women and men over 18 years of age * first acute myocardial infarction with st elevation, within 6 hours of the initial symptoms, that are admitted for primary pci at the hospital san bernardo. * timi 0 or 1 flow in the culprit artery. exclusion criteria: * not able or willing to give informed consent. * participate in another protocol. * pregnancy. * history of any of the diseases listed: cardiomyopathy, valvular disease severe, any disease with a life expectancy of less than 1 year. * contraindication for protocol drugs (dextran). * lbbb or pacemaker. * prolonged cardiopulmonary resuscitation. * cardiogenic shock. * left main coronary lesion or culprit lesion in venous graft. * large artery not feasible for pci, guilty vessel of small caliber or very distal lesion.

Keywords: acute myocardial infarction reperfusion injury
evaluation of the pheno4u data platform in patients undergoing total knee arthroplasty

Conditions: Degenerative Osteoarthritis; Rheumatoid Arthritis; Posttraumatic Arthropathy; Chronic Instability of Knee; Stiffness of Knee; Deformity Knee

Summary: prospective, multinational pilot study for evaluation of the pheno4u data platform in total knee arthroplasty (tka) patients

the study will collect data for each patient receiving an aesculap total knee arthroplasty (tka) implant. the data set will be analyzed for critical risk factors among implant and patient data in order to optimize patient-centered therapies. the products under investigation will be used in routine clinical practice and according to the instructions for use (ifu). data obtained in routine clinical use will be collected in the pheno4u data platform. in addition, patients are expected to answer questionnaires about their health status. furthermore, patients are asked to use the so called "bpmpathway" sensor and application in order to measure the active range of motion (rom). the sensor can also be used for pre- and postoperative training .

Eligibility criteria:
inclusion criteria: * patient undergoing a total knee arthroplasty with a b. braun knee implant system * signed written informed consent * patient's willingness \& ability to use the "bpmpathway"sensor * patient's willingness \& ability to use the "4patient" application exclusion criteria: * patient age \< 18 years * patient not willing to participate at the further follow-up * pregnancy * if intraoperatively an implant from a different manufacturer is used, the study patient has to be excluded from the study.

Keywords: bi-condylar knee replacement severe knee joint conditions patient reported outcome
the safety and feasibility of monofix on fascial closure of mid-line wound after minimally invasive colorectal cancer surgery

Conditions: Colon Cancer; Rectal Cancer; Colon Adenocarcinoma; Rectal Adenocarcinoma

Summary: this clinical trial aims to evaluate the safety and feasibility of mid-line fascial suturing using monofix sutures in patients undergoing minimally invasive surgery for colorectal cancer.


Eligibility criteria:
inclusion criteria: * colorectal adenocarcinoma * elective (or planned) curative surgery * laparoscopic surgery * midline incision less than 10 cm exclusion criteria: * previous laparotomy with midline incision more than 10cm. * systemic chemotherapy for any cause within the last 6 months.

Keywords: minimally invasive surgery barbed suture
effect of modified lumbar sustained natural apophyseal glide on postnatal low back pain

Conditions: Low Back Pain

Summary: this study will be carried out to evaluate the effect of modified lumbar sustained natural apophyseal glide on low back pain in postnatal women.

in fact, up to 75% of women who suffer from pregnancy-related back pain may continue to have pain after giving birth. women who experience lbp or pelvic girdle pain (pgp) at 3 months postpartum were found to be at higher risk for persistent or chronic lbp. of these women, only 6% recover within 6-18 months after giving birth. a modified lumbar sustained natural apophyseal glide (snag) is an existing mulligan mobilization technique performed with a combination of joint glide and physiological spinal movement. the glide can be applied to the spinous processes, facets, or unilaterally over the transverse processes while the patient performs the active exercise. few studies have been concerned with the effects of modified "snags" on the lumbar spine . so, this study will be done to investigate its effect on low back pain in postnatal women aiming to improve their function to accomplish their daily living activities and reduce the side effects of medical treatment.

Eligibility criteria:
inclusion criteria: 1. all participants will be diagnosed as chronic postnatal low back pain. 2. their ages will be ranged from 20 to 35 years old. 3. their body mass index (bmi) will not exceed 30 kg/m2. 4. all participants have the same social level. 5. all participants have the same lifestyle. 6. their number of parity will be ranged from 2-4 children. exclusion criteria: 1. spinal fracture or any other neurological disorders. 2. lumbar spinal stenosis from lumbar disc herniation, degenerative joint diseases, or spondylolisthesis. 3. women with bmi \> 30 kg/m2. 4. participants who had pelvic pathology. 5. skin disease interferes with mobilization application. 6. gynecological diseases (chronic pelvic pain, uterine prolapse and retroversion flexion of the uterus).
qualitative exploratory study among reunionese women and their partners who have a child with trisomy 21

Conditions: Down Syndrome

Summary: according to data from french congenital malformation registries, the prevalence of down syndrome (ds) in 2017 (live births and medical termination of pregnancy (mtop)) in reunion island was the lowest in france (23.04 per 10,000 births), notably in relation to a young maternal age. however, if we look at live births, reunion island has the highest prevalence of ds in france (12.24 vs. 5.81 per 10,000 births), despite a well organized prenatal diagnosis (pnd). in fact, the use of mtop in this context is the lowest in france (10.8 vs 26.3 per 10 000 births). local specificities may have an impact on the choice of patients to undergo or not undergo a mtop in the context of pnd of ds and explain why the rate of recourse to mtop is the lowest in france. to date, no qualitative study exploring the reasons why women and their partners do not undergo a mtop in the context of ds has been conducted in reunion island. thus, the main hypothesis is that the low recourse to mtop following pnd of ds in reunion island could be explained by the beliefs, values or choices of reunion island women and their partners during pregnancy in relation to a specific family, socio-cultural and economic context.


Eligibility criteria:
inclusion criteria: parents: * of a child born alive with down syndrome as of january 1, 2019 and registered within remacor * living on the island of reunion at the time of birth * having a good understanding of french and/or creole * having given their written consent to the study exclusion criteria: parents: * with normal/negative prenatal screening (false positive) * minors at the time of inclusion * under guardianship or legal protection * with a pathology preventing the interviews from taking place
management of transitory loss of consciousness and syncopes in the emergency department

Conditions: Syncope; Unconscious State

Summary: the goal of this observational study is to examine the clinical presentations, the diagnostic tests performed and the management of patients presenting with transient loss of consciousness (tloc) the main questions it aims to answer are: * prevalence of tloc * prevalence of different diagnoses leading to tloc demographic, clinical, paraclinical and biological data will be collected from the emergency medical file

patients over the age of 18 presenting to the university hospital of clermont-ferrand emergency department for transient loss of consciousness of syncopal or undifferentiated origin will be include. their non-opposition will be sought. demographic, clinical, paraclinical and biological data will be collected from the emergency medical file. no visit is planned after the passage to the emergency room.

Eligibility criteria:
inclusion criteria: * patients over 18 presenting to the clermont-ferrand university hospital emergency department for transient loss of consciousness of syncopal or undifferentiated origin exclusion criteria: * n/a

Keywords: transient loss of consciousness syncope emergency department
radiotherapy by sonic hedgehog pathway inhibitors in basal cell carcinoma

Conditions: Basal Cell Carcinoma; Radiotherapy; Complications

Summary: locally advanced basal cell carcinoma (bcc) are large bccs or bccs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. in these particular situations, surgery and radiotherapy are sometimes not appropriate, and sonic hedgehog inhibitors (shhi) (vismodegib and sonidegib) can be proposed. shhi are effective treatments in labcc but most cr patients discontinue treatment because of tolerability. approximately 65% of the population experience a relapse after discontinuation. a few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. there is no study evaluating a "consolidation radiotherapy" after complete response to shhi. we carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with labcc after achieving complete response with shhi, with the hypothesis of reducing recurrence after discontinuation of shhi.


Eligibility criteria:
inclusion criteria: * patient over 18 years * locally advanced non-recurrent bcc in complete response after first course of shhi * complete response has to be confirmed histologically * available photography or ct scan before shhi treatment allowing delineation of the initial tumor exclusion criteria: * patients with distant metastasis * patients with gorlin's syndrome * prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields * pregnant women * life expectancy less than 1 year * inability to receive informed consent * inability to participate in the entire study * lack of social security coverage * refusal to sign consent

Keywords: locally advanced basal cell carcinoma sonic hedgehog inhibitors consideration radiotherapy
study watch atrial fibrillation (af) detection investigation

Conditions: Atrial Fibrillation

Summary: this is a prospective, non-randomized study to refine the study watch's algorithm for af detection within both persistent and paroxysmal af subjects. the study will also collect data from an fda-cleared wearable ecg sensor.


Eligibility criteria:
inclusion criteria: * at least 18 years old * able to read and speak english * able and willing to sign written informed consent * interest in participating in the study * subjects with a known history of af (including persistent or paroxysmal af) * without significant limitation in ability to participate in the study, in the opinion of the investigator. exclusion criteria: * currently in a paced rhythm * known severe allergy to nickel or metal jewelry * known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
bilevel positive pressure ventilation (bipap)in patients with sleep disorders breathing (sdb)and congestive heart failure (chf):comparison of two diagnostic methods

Conditions: Symptomatic Congestive Heart Failure

Summary: successful treatment of pulmonary edema was first published in 1938 by a. l. barach. since then, this has been the accepted method of treating acute respiratory failure due to left heart failure and edema. the question was raised if pressure supported ventilation during sleep is used to eliminate sleep apneas, would it be useful also for improving congestive heart failure (chf). recent studies assessed the role of continuous positive airway pressure (cpap) in patients with advanced chf and found the treatment useful. a possible explanation for these results is that central sleep apnea frequently coexists with severe chf and is not treated or suppressed by cpap. the frequency of central sleep apnea increases with the severity of chf and can be found in more than 30% of patients. a few recent studies showed the usefulness of bilevel positive airway pressure (bipap) or adaptive servo-ventilation (asv). asv led to improvement in ejection fraction as well as in 6 min walking distance testing, and was associated with decreased bnp levels. in another study, bilevel pap increased lvef by 7.9%. the limitations of these studies are the small number of patients and that they were conducted on inpatients only. these factors make it difficult to include bipap in the guidelines for chronic heart failure therapy. recently, two outpatient modalities have been introduced to diagnose sleep disordering breathing (sdb). however, no study has directly compared the results of both studies in patients with chf. moreover, no studies have assessed improvement in chf after bipap treatment. in addition, the investigators plan to assess the endothelial function in this population before and after bipap treatment with the endopat, a noninvasive technology


Eligibility criteria:
inclusion criteria: * age \> 18 years * patients that will be able to sign an informed consent * able to use bipap equipment * established diagnosis of congestive heart failure exclusion criteria: * patients who cannot acquire bipap from the health care system or who are unable to use the bipap. * patients who will be not able to visit the clinic for follow up.

Keywords: chf watch-pat embletta x endothelial function
integrating interventions for maternal substance abuse

Conditions: Substance Abuse; Child Neglect

Summary: this research plan proposes stage 1 research integrating evidence based practices to address the needs of mothers referred to child welfare for substance abuse. mothers with a history of methamphetamine abuse and child neglect will be recruited. using an intensive community based treatment, mothers will receive substance abuse treatment combined with parenting skills training and psychosocial support for basic needs (e.g., housing, employment). this project will include a feasibility study (n = 5), followed by a small randomized pilot (n = 24) to examine the efficacy of the integrated treatment for substance abuse and neglect compared to treatment as usual, with a population of substance abusing neglectful mothers referred through the department of child welfare.


Eligibility criteria:
inclusion criteria: * maternal substance abuse * child welfare involvement * child neglect * english speaking * child either remaining in the home or reunification plan in place * living in the county exclusion criteria: * current involvement in other substance abuse treatment * current involvement in other parenting skills training * parental rights terminated * active psychosis

Keywords: methamphetamine substance abuse child neglect child welfare evidence based practice
characterizing lam with 11c-choline pet/ct

Conditions: Lymphangioleiomyomatosis

Summary: it was reported that tsc2-deficient cells enhance phosphatidylcholine synthesis via the kennedy pathway. 11c-choline can reflect the metabolic process of choline in vivo by intravenous injection. the purpose of this study is the ability of 11c-choline pet/ct to evaluate the baseline condition of lam patients and the efficacy of rapamycin after treatment.

tuberous sclerosis complex (tsc) is an autosomal dominant disorder caused by inactivating mutations of the tsc1 or tsc2 gene, characterized by neurocognitive impairment and benign tumors of the brain, skin, heart, and kidneys. lymphangioleiomyomatosis (lam) is a diffuse proliferation of α-smooth muscle actin-positive cells associated with cystic destruction of the lung. lam occurs almost exclusively in women, as a tsc manifestation or a sporadic disorder (tsc1/tsc2 somatic mutations). biomarkers of whole-body tumor burden/activity and response to rapalogs or other therapies remain needed in tsc/lam. it was reported that tsc2-deficient cells enhance phosphatidylcholine synthesis via the kennedy pathway. 11c-choline can reflect the metabolic process of choline in vivo by intravenous injection. the purpose of this study is the ability of 11c-choline pet/ct to evaluate the baseline condition of lam patients and the efficacy of rapamycin after treatment.

Eligibility criteria:
inclusion criteria: - provide a written informed consent; diagnostic ct or mri suggesting a diagnosis of lymphangioleiomyomatosis. exclusion criteria: - females planning to bear a child recently or with childbearing potential; known severe allergy or hypersensitivity to iv radiographic contrast； inability to lie still for the entire imaging time.